The invention relates to pellets containing active substances and having a polymer coating and a mean particle size of between 300 and 1100 μm. Said pellets contain a pharmaceutically active substance which is integrated into a polymer matrix consisting of at least one polymer. The pellets according...http://www.google.nl/patents/WO2008101554A1?cl=en&utm_source=gb-gplus-sharePatent WO2008101554A1 - Pellets comprising an active substance matrix and a polymer coating, and a method for producing said pellets

Pellets comprising an active substance matrix and a polymer coating, and a method for producing said pelletsWO 2008101554 A1

Samenvatting

The invention relates to pellets containing active substances and having a polymer coating and a mean particle size of between 300 and 1100 μm. Said pellets contain a pharmaceutically active substance which is integrated into a polymer matrix consisting of at least one polymer. The pellets according to the invention are characterised in that they have a maximum friability of 0.1 %, measured with 200g of pellets on a 200 m sieving machine with a sieve diameter of 20 cm and 1.5 mm of shaking amplitude at a shaking frequency of 50 1/sec for 10 min in the presence of six rubber cubes having a 1.8 cm long edge. Said pellets also have a polymer coating consisting of an anionic (meth)acrylate copolymer on the condition that, during the release test according to USP, the pellets release no more than 10 % of the active substance in the artificial gastric juice at a pH of 1.2 after 120 min.

23. Multipartikuläre Arzneiform, enthaltend ein oder mehrere Pellets nach einem oder mehreren der Ansprüche 1 bis 19. 23. A multiparticulate pharmaceutical form comprising one or more pellets according to one or more of claims 1 to nineteenth

Die Erfindung betrifft weiterhin multipartikuläre Arzneiformen, enthaltend ein oder mehrere der erfindungsgemäßen Pellets. The invention further relates to a multiparticulate dosage forms containing one or more of the pellets according to the invention.

Die Friabilität der erfindungsgemäßen Pellets wird daher durch einen modifizierten Test mit gegenüber dem Standardtest verschärften Bedingungen beschrieben. The friability of the pellets according to the invention is therefore described by a modified test with respect to the standard test more stringent conditions.

Die Zugabe der Weichmacher zur Formulierung kann in bekannter Weise, direkt, in wässriger Lösung oder nach thermischer Vorbehandlung einer Mischung vorgenommen werden. The addition of the plasticizer to the formulation can be carried out directly in aqueous solution or after thermal pretreatment of a mixture in a known manner.Auch können Mischungen von Weichmachern eingesetzt werden. Mixtures of plasticizers can also be used.